Senior Design Quality Engineer for MedTech Hardware

Becton Dickinson; San Diego (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

Becton, Dickinson and Company in San Diego, CA is seeking a Design Quality Engineer to support sustaining engineering for hardware medical devices. You will participate in design controls, risk management, and verification/validation planning to ensure compliance with FDA/ISO requirements.

The role requires 3+ years in design quality for electromechanical products and hands-on experience with design transfer, V&V activities, and post-market risk assessments.

Qualifications

• Bachelor's degree in Engineering or related field required; Master’s preferred.
• 3+ years of Design Quality Engineering experience in hardware medical devices or electromechanical products.
• Strong knowledge of FDA QSR (21 CFR Part 820) and ISO 13485; experience with design controls and ISO 14971.

Responsibilities

• Act as the Quality core team member for sustaining engineering projects.
• Participate in design control activities, including design reviews, risk management, and verification and validation planning and execution.
• Support development and maintenance of design and development files (DDFs) to ensure compliance with internal procedures and external regulations (FDA, ISO 13485).
• Perform and review risk management activities including Hazard Analysis, FMEA, and risk-benefit analysis with identified mitigation strategies.
• Provide quality engineering support for CAPA activities, investigations, and verification of effectiveness to ensure sustained compliance.
• Author field issue assessments using post-market data, complaint investigations, and risk analyses in compliance with 21 CFR 806 and EU MDR.
• Participate in internal and external audits (FDA, Notified Body).
• Mentor junior quality engineers and provide technical guidance on design quality principles and practices.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, Marketing to meet quality objectives.
• Develop and implement quality plans, procedures, and work instructions to enhance the Quality Management System.
• Identify opportunities for continuous improvement within the quality organization.

Skills

Quality engineering

Risk analysis

Analytical thinking

Communication skills

Education

Bachelor's degree in Engineering

Master's degree (preferred)

Tools

Minitab

JMP

Job description

Becton, Dickinson and Company in San Diego, CA is seeking a Design Quality Engineer to support sustaining engineering for hardware medical devices. You will participate in design controls, risk management, and verification/validation planning to ensure compliance with FDA/ISO requirements.

The role requires 3+ years in design quality for electromechanical products and hands-on experience with design transfer, V&V activities, and post-market risk assessments.